Chelsea confirms early droxidopa data

US drug developer Chelsea Therapeutics has completed a second analysis of data from the open-label titration portion of its Phase III Study  302, which demonstrated that patients treated with droxidopa, an  orally-active synthetic precursor of norepinephrine, for the treatment  of intradialytic hypotension, showed a similar reduction in the severity  of symptoms associated with neurogenic orthostatic hypotension and an  improvement in standing systolic blood pressure as in the first trial.

Patients identified as responders during the open-label titration phase  of the study, and therefore eligible for inclusion in the double-blind,  randomized trial, demonstrated a mean improvement of 4.2 units on Item 1  (dizziness or light-headedness) of the Orthostatic Hypotension Symptom  Assessment scale during titration and a mean improvement in standing  systolic blood pressure of 25 mmHg. The average baseline OHSA score for  responders prior to treatment was 6.3 and the average score at the end  of the titration was 2.1. The OHSA is a validated scale designed to rate  symptoms occurring specifically as a result of low blood pressure and  uses an 11-point scale (zero to 10).

Study 302 was one of two Pivotal Phase III trials comparing droxidopa to  placebo for the treatment of symptomatic neurogenic orthostatic  hypotension. The other trial, Study 301, was reviewed by the US Food and  Drug Administration and awarded a special protocol assessment in  February last year.